Scandinavian Candesartan Acute Stroke Trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2500

Inclusion Criteria

1. Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour).
2. Systolic blood pressure = 140 mm Hg (see paragraph 7.1 for details).
3. Trial treatment possible within 30 hrs of symptom onset. If time of onset is not known, use the time when the patient was last known to be well.
4. Consent (subsidiary, assent from legal acceptable representative, or waiver of consent, see paragraph 7.2 in protocol for details).
5. Age >18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Markedly reduced consciousness (e.g. Scandinavian Stroke Scale consciousness score = 2)
2. Patient already receiving AT1 receptor blocker
3. Contraindication to treatment with AT1 receptor blocker, e.g.:
• known renal failure (women: creatinine = 150 µmol/L; men: = 180 µmol/L)
• previously diagnosed bilateral renal artery stenosis
• previously diagnosed high-grade aortic stenosis
• previously diagnosed seriously impaired liver function and/or cholestasis
• known intolerance to candesartan or other tablet ingredients
4. Clear indication, in the clinician’s view, for start of treatment with AT1 receptor blocker during the treatment period
5. Clear indication, in the clinician’s view, for antihypertensive therapy during the acute phase of stroke (i.e. concurrent hypertensive encephalopathy or aortic dissection, or other situations)
6. Other serious or life-threatening disease before the stroke:
• patient severely mentally or physically disabled (e.g. Mini Mental Status score < 15-20, or modified Rankin Scale score = 4)
• life expectancy < 12 months
7. Patient unavailable for follow-up (e.g. no fixed address)
8. Pregnant or breast-feeding woman

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 8/8/2022